Intensive Smoking Cessation Invervention for Head and Neck Cancer Patients

描述（由申请人提供）：烟草是头颈部癌症的主要危险因素。有证据表明，头颈癌患者在诊断后继续吸烟，其发生第二原发肿瘤、复发、治疗反应降低和生存率降低的风险增加。尽管头颈部疾病患者在诊断后戒烟的比例很高，但md安德森癌症中心（MDACC）烟草治疗计划（TTP）和其他研究的数据表明，28%至46%的患者继续吸烟。MDACC TTP和其他研究的数据还表明，在诊断后继续吸烟的头颈癌患者中，有很大一部分人存在多种因素，这些因素可能使他们戒烟的努力复杂化，包括高度的尼古丁依赖，与癌症相关的高度情绪困扰，以及共病的抑郁、焦虑和酒精使用障碍。这表明，这一亚群患者可能需要强化治疗，以更有效地解决这些戒烟障碍。本研究的目的是为诊断后继续吸烟的头颈部患者开发一种强化戒烟干预措施，该干预措施基于接受和承诺疗法（ACT），这是一种现有的治疗方法，已被发现对治疗癌症患者的吸烟，物质依赖障碍和痛苦有效；进行一项小型初步随机试验，以检查其对短期和长期点患病率和长期戒烟的影响，以及与现有动机和行为戒烟治疗（MBC）相关的生活质量；评估ACT的假设治疗机制是否介导ACT对戒断的影响，以及这些中介是否与介导MBC对戒断的影响的变量不同。该项目将分两个阶段进行。在第一阶段（Ia阶段），我们将修改现有的接受和承诺疗法治疗方案的内容，用于诊断后继续吸烟的头颈部患者的戒烟干预。在这一阶段，通过MDACC TTP招募的20名头颈部患者将完成该方案，该方案将根据患者、ACT治疗专家和研究治疗师的反馈进行修改和完善。在第二阶段（Ib期），67名诊断后继续吸烟的头颈部患者将通过MDACC TTP招募，并随机分配到ACT或TTP标准MBC治疗。在这两种情况下，伐尼克兰将作为治疗的一部分。根据这一初步试验的结果，ACT治疗方案将进一步完善，并准备进行更大规模的临床试验。公共卫生相关性：本研究的目的是为诊断后继续吸烟的头颈部患者开发一种强化戒烟干预措施，并提供其有效性的初步信息。接受与承诺疗法（ACT）是一种现有的治疗方法，已被发现对治疗癌症患者的物质使用障碍和痛苦有效。我们将修改和发展这种治疗方法，作为戒烟干预措施，然后进行一个小型试验，看看与目前可用的咨询治疗相比，ACT在帮助头颈癌患者戒烟和改善生活质量方面是否更有效。如果ACT被发现更有效，它可以在更大规模的研究中进一步测试。

DESCRIPTION (provided by applicant): Tobacco is a primary risk factor for cancers of the head and neck. There is evidence that patients with head and neck cancer who continue to smoke following diagnosis are at increased risk for developing second primary tumors, recurrence, reduced response to treatment, and reduced survival. Although a high percentage of head and neck patients abstain from smoking following diagnosis, data from the M.D. Anderson Cancer Center (MDACC) Tobacco Treatment Program (TTP) and other studies suggest that 28 percent to 46 percent of patients continue to smoke. Data from the MDACC TTP and other studies also indicate that a high proportion of head and neck cancer patients who continue to smoke following diagnosis present with a variety of factors that may complicate their efforts to quit, including high levels of nicotine dependence, high levels of emotional distress related to their cancer, and comorbid depressive, anxiety and alcohol use disorders. This suggests that this subpopulation of patients may need an intensive treatment that more effectively addresses these barriers to cessation. The goals of this study are to develop an intensive smoking cessation intervention for head and neck patients who continue to smoke following diagnosis that is based on Acceptance and Commitment Therapy (ACT), an existing treatment that has been found to be efficacious in the treatment of smoking, substance dependence disorders, and distress in cancer patients; to conduct a small preliminary randomized trial to examine its effects on both short and long-term point prevalence and prolonged abstinence, and quality of life relative to an existing motivational and behavioral smoking cessation treatment (MBC); and, to evaluate whether ACT's hypothesized treatment mechanisms mediate ACT's effect on abstinence and whether these mediators differ from variables that mediate MBC's effect on abstinence. The project will take place in two phases. In the first phase (Stage Ia), we will modify content from existing Acceptance and Commitment Therapy treatment protocols for use as a smoking cessation intervention for head and neck patients who continue to smoke following diagnosis. During this phase, 20 head and neck patients recruited through the MDACC TTP, will complete the protocol, which will be modified and refined based upon feedback from patients, ACT treatment experts, and study therapists. In the second phase (Stage Ib), 67 head and neck patients who continue to smoke following diagnosis will be recruited through the MDACC TTP and randomly assigned to either ACT or the TTP standard MBC treatment. Varenicline will be included as part of treatment in both conditions. Based on the outcome of this preliminary trial, the ACT treatment protocol will be further refined and readied for larger-scale clinical trials. PUBLIC HEALTH RELEVANCE: The goal of this study is to develop an intensive smoking cessation intervention for head and neck patients who continue to smoke following diagnosis, and to provide preliminary information about its effectiveness. Acceptance and Commitment Therapy (ACT) is an existing treatment that has been found to be effective in the treatment of substance use disorders and distress in cancer patients. We will modify and develop this treatment as a smoking cessation intervention and then run a small trial to see whether ACT is more effective in helping head and neck cancer patients quit and in improving their quality of life, compared to the currently available counseling treatment. If ACT is found to be more effective, it could be further tested in larger studies.